Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome

NCT05843968 | Recruiting Phase 2

• 1 other identifier: HYang
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).

Conditions

Nephrotic Syndrome in Children

Keywords

Nephrotic Syndrome; Rituximab; Mycophenolate Mofetil

Outcome Measures

Primary Outcomes (1)

• 12-month relapse-free survival rate

  The rate of no relapse within 12 months.

  12 months

Secondary Outcomes (13)

• 6-month relapse-free survival

  6 months

• 6-month relapse-free survival rate

  6 months

• 12-month relapse-free survival

  12 months

• Proportion of frequent relapses

  Months 6,12

• Cumulative steroid dosage

  12 months

Study Arms (2)

Rituximab

EXPERIMENTAL

2 doses of rituximab 375 mg/m\^2 (Maximum 500mg/day)at 6 months intervals

Drug: Rituximab

Mycophenolate Mofetil

ACTIVE COMPARATOR

MMF 20\~30mg/kg/day，BID

Drug: Mycophenolate Mofetil

Interventions

Rituximab DRUG

2 doses of rituximab 375 mg/m\^2(maximum 500mg/day) at 6 months intervals. Half an hour before rituximab infusion: oral acetaminophen 15mg/kg, oral or intramuscular antihistamine, methylprednisolone 2mg/kg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.

Also known as: Rituximab Injection

Rituximab

Mycophenolate Mofetil DRUG

Mycophenolate Mofetil 20-30 mg/kg/day BID,then adjust the dosage of drugs(maximum 2g/day) to maintian the concentration for MPA-AUC is 30-50μg.h/ml. Total duration:1year. Steroids dose:1.5mg/kg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg/kg every 2 weeks

Also known as: Mycophenolate Mofetil Dispersible tablets

Mycophenolate Mofetil

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with a definite diagnosis of SDNS are included in the study during relapse treatment.
• Age 3-16 years.
• Steroid dependent dose≤0.3mg/kg/day.
• Cumulative steroid use for ≥6 months.
• Ability to swallow tablet.
• Guardians understand the characteristics and personal consequences of clinical trial.
• Guardians willing to give informed written consent.

You may not qualify if:

• Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc.
• Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased.
• Diagnosis of hereditary nephrotic syndrome.
• Full dose of prednisone (2mg/kg/day, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative.
• Estimated glomerular filtration rate (eGFR) \<90mL/min per 1.73m\^2 at study entry.
• Those who with a known allergy to Mycophenolate Mofetil and their excipients or to Rituximab and its excipients.
• Those who refuse to participate in the trial.
• Those who participate other clinical trials.
• Those who with positive HBV serological markers (HBsAg or/and HBeAg or/and HBcAb), HCV positive patients or patients with abnormal liver function (ALT,AST,or bilirubin\>2 or more times the upper limit of the normal range and persistently elevated for 2 weeks).
• Severe leukopenia (white blood cells\<3.0×10\^9), severe anemia (hemoglobin\<90g/l), and thrombocytopenia (platelets\<100×10\^9) at study entry.
• History of pancreatitis or definite gastrointestinal ulcers and/or gastrointestinal bleeding within 6 months.
• Those who with congenital or acquired immune deficiency, or with active tuberculosis, active CMV and other infections.
• Those who with other serious physical or mental illnesses.
• History of malignant tumor within 5 years.
• Those who with congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (1)

• Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

  PMID: 39513526 DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Rituximab; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Central Study Contacts

Yang Haiping, Doctor

CONTACT

8618983703661; oyhp@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Nephrology

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: May 6, 2023
• Study Start: January 29, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)